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U.S. Department of Health and Human Services

Class 2 Device Recall GENERAL ANGIO PACK

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 Class 2 Device Recall GENERAL ANGIO PACKsee related information
Date Initiated by FirmFebruary 06, 2025
Date PostedMarch 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1340-2025
Recall Event ID 96343
Product Classification Angiography/angioplasty kit - Product Code OEQ
ProductGENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Code Information UDI-DI 00191072219510 Lots 70-050850 70-051285 70-051779 70-051779A 70-052186 70-052669 70-053022
Recalling Firm/
Manufacturer		 American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
For Additional Information ContactMarlene Jones
419-455-2090
Manufacturer Reason
for Recall		ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA Determined
Cause 2		Process control
ActionThe affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Quantity in Commerce956 kits
DistributionUS Nationwide distribution in the state of OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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